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The correct functioning, the life span and the validity of the CE marking of a medical device is subject to the prompt and correct maintenance programme carried out as indicated by the Manufacturer in the Instructions Manual and as prescribed ...
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Items introduced onto the markets of the European Community must meet the minimum safety requirements as indicated in the directive “new approach” with indications for each single item.
As Directives have not been created for every product, the European Community ...
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Medical Devices manufactured by Spencer Italia S.r.l. are made in full respect of the essential requirements of the Medical Devices Directive 93/42/EC (and updates) for the product’s technical requirements and are manufactured following the Good Manufacturing Practice.
Ad indicated in the ...
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